Bioequivalence and Bioavailability Forum

This monkey business [Power / Sample Size]

posted by Helmut  – Vienna, Austria, 2013-06-13 22:04 (4755 d 12:32 ago) – Posting: # 10781
Views: 14,475

Hi John!

❝ ❝ […] IMHO FDA wants at least 24 subjects.

❝

❝ n≥12 is what FDA wants.

Yes, for 2×2. Do you have a reference that 12 are enough for scaling?

❝ ❝ Hhm, why don’t you save the money (or wire somefink to my bank account instead) and submit the pilot study as pivotal evidence of BE?

❝

❝ I asked the Senior mgt too and they said it's a pilot batch but manufactured with pivotal specification. I don't understand their answer. I will go digging and see if they know what they are talking about.

❝ ❝ Or the GMR and/or CV go loony and jump around between studies. Wouldn’t surprise me with a CV of 60%…

❝

❝ That's my concern now since we are only 5% away from failing the T/R ratio.

Yes, it will be a close shave.

❝ ❝ Power. That which statisticians are always calculating

❝ ❝ but never have. Stephen Senn

❝

❝ Corporate decision comes first

Sigh.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• This power business jag009 2013-06-13 16:49 
  • This monkey business Helmut 2013-06-13 17:40
    • This monkey business jag009 2013-06-13 19:57
      • This monkey businessHelmut 2013-06-13 20:04
        • This monkey business jag009 2013-06-13 21:24
          • This monkey business Helmut 2013-06-13 21:33
            • This monkey business jag009 2013-06-13 21:42
              • This monkey business Helmut 2013-06-13 22:12
                • This monkey business jag009 2013-06-13 23:06
                  • Minimum sample size for RSABE = 24 (enrolled) Helmut 2013-06-14 15:43
                    • Minimum sample size for RSABE = 24 (enrolled) jag009 2013-06-14 22:06
      • This monkey business ElMaestro 2013-06-14 01:57
        • This monkey business jag009 2013-06-14 20:49